FDA Medical Device Annual Registration/Renewal Open
Owners or operators of establishments that produce and distribute medical devices intended for use in the U.S. are required to register annually with the U.S. Food and Drug Administration (FDA). This includes domestic and foreign establishments, such as manufacturers, exporters, and initial importers. The registration must be submitted electronically, unless a waiver to the electronic process has been granted. The annual registration fee this year is $7,653.
The registration deadline is December 31, 2023. Failure to register or renew an establishment registration will result in an FDA detention or refusal of the medical device products. For more information regarding device registration, please refer to the FDA’s website.